TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2011-001180-53

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy

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Extrait

To demonstrate the non-inferiority of TMC435 versus TVR, both given in combination with PegIFNα-2a and RBV, by less than 12%, with respect to the proportion of subjects with SVR 12 weeks after the planned end of treatment (SVR12).


Critère d'inclusion

  • Hepatitis C Virus (HCV) genotype-1 infection